Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study).
Am J Respir Crit Care Med
; 187(11): 1212-8, 2013 Jun 01.
Article
em En
| MEDLINE
| ID: mdl-23525935
ABSTRACT
RATIONALE Limited cross-sectional data exist to characterize the challenges of enrolling critically ill patients into research studies. OBJECTIVES:
We aimed to describe recruitment practices, document factors that impact recruitment, and identify factors that may enhance future research feasibility.METHODS:
We conducted a prospective, observational study of all critically ill adults eligible to participate in research studies at 23 Canadian intensive care units. We characterized eligibility events into one of five consent outcomes, identified reasons why opportunities to recruit were missed or infeasible, and documented decision maker's rationale for providing or declining consent. MEASUREMENTS AND MAINRESULTS:
Patients made decisions for themselves in 8.9% of encounters. In 452 eligibility events, consent was not required in 14 (3.1%), missed in 130 (28.8%), infeasible due to operational reasons in 129 (28.5%), obtained in 140 (31.0%), and declined in 39 (8.6%). More than half (57.3%) of all opportunities to recruit patients were missed or infeasible, largely because of research team workload, limited availability, narrow time windows for inclusion, difficulties in contacting families, nonexistent substitute decision makers (SDMs), physician refusals, and protocols prohibiting coenrollment. The rationale for providing consent differed between patients and SDMs. Greater research coordinator experience and site research volume and broader time windows for inclusion were significant predictors of fewer declined consents.CONCLUSIONS:
A large gap exists between eligibility and the frequency with which consent encounters occur in intensive care unit research. Recruitment is susceptible to design and procedural inefficiencies that hinder recruitment and to personnel availability, given the need to interact with SDMs. Current enrollment practices may underrepresent potential study populations.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Estado Terminal
/
Seleção de Pacientes
/
Cuidados Críticos
/
Tomada de Decisões
/
Consentimento Livre e Esclarecido
Tipo de estudo:
Clinical_trials
/
Guideline
/
Observational_studies
/
Prevalence_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Am J Respir Crit Care Med
Assunto da revista:
TERAPIA INTENSIVA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Canadá